ObjectiveTo systematically investigate the registration status, methodology and reporting quality of the systematic review protocols for animal experiment registered on PROSPERO platform.MethodsSystematic review protocols of animal experiments registered on PROSPERO platform were searched up to December 31st, 2019. Two reviewers independently screened literature, extracted data, and performed a descriptive analysis of the methodological quality and reporting characteristics of the included studies.ResultsA total of 351 protocols from 50 countries were included, involving 22 diseases. The intervention measures were primarily "pharmaceutical chemicals". Only approximately 1/3 of the studies reported the search strategy from at least one database, approximately half of the studies were prepared to report heterogeneity analysis and publication bias, and only approximately 1/3 of the studies were prepared to report sensitivity analysis.ConclusionsThe quantity of systematic reviews of animal experiments registered on the PROSPERO platform is increasing annually, however, there are still some limitations in the methodology and reporting quality.
Objective To explore and solve the key technologies of the three dimensional (3D) visual ization reconstruction of functional fascicular groups inside long segmented peri pheral nerve. Methods A 20 cm ulnar nerve from upper arm of fresh adult dead body was embedded by OCT with four pieces of woman’s hair which was used as locating material, then the samples were serially horizontally sl iced into 400 sl ices with 15 μm thickness and 0.5 mm interval. All sl iceswere stained with acetylcholinesterase (AchE) histochemical staining. After that, the 2D panorama images of the same sl ice were obtained with Olympus stereomicroscope and MSHOT MD90 micro figure image device before and after AchE staining. Using the layer processing technique of Photoshop image processing software, the recomposition images including complete 4 location pots were obtained, based on which the algorithm of optimized least square support vector machine (Optimized LS-SVM) and space transformation method was used to fulfill automatic registration. Finally, with artificial assistant outline obtaining, the 3D visual ization reconstruction model of functional fascicular groups of 20 cm ulnar nerve was made using Amira 4.1, and the effects of reverse reduction and the suitabil ity of 3D reconstruction software were evaluated. Results The two-time imaging technique based on the layer process of Photoshop image processing software had the advantages: the image outline had high goodness of fit; the locating pots of merging image was accurate; and the whole procedure was simple and fast. The algorithm of Optimized LS-SVM had high degree of accuracy, and the error rate was only 8.250%. The 3D reconstruction could display the changes of the chiastopic fusion of different nerve functional fascicular groups directly. It could extract alone, merge and combine arbitrarily, and revolve at any angles. Furthermore, the reverse reduction on arbitrarily level dissection of the 3D model was very accurately. Conclusion Based on the two-time imaging technique and computer image layer processing technology, the compute algorithm of auto-registration can be developed and appl ied to 3D visual ization reconstruction of long segmented peripheral nerve. The technological processes is fast, and the reconstruction effect is good.
ObjectiveTo review the characteristics of registered industry-sponsored clinical trials of pediatric drugs and vaccines in China and to provide references for promoting the development of new pediatric drugs. MethodsWe searched ClinicalTrials.gov and the Chinese Clinical Trial Registry for completed registered industry-sponsored clinical trials of pediatric drugs and vaccines from the database inception to September 11, 2022. Data including the date the trial was first posted, product type (drug or vaccine), sample size, and other information to describe the general characteristics of pediatric clinical trials were collected. The studies were divided into 2 phases based on the trial posted date, 2005―2010 and 2011―2022, reflecting the enactment of pediatric drug clinical trial policies in recent years. The quality of trial registration and the main characteristics of interventional trials in the 2 phases were then compared. Exploring the results attached to industry and non-industry sponsored clinical trials. ResultsData for 145 trials were collected, and the largest proportion (63.4%) involved vaccines. Randomized control trial (RCT) was the study type with the highest percentage (68.3%). The average report completion rate for registered interventional trials was 81.0%. Compared with 2005―2010, the percentage of average report completions, pediatric drug clinical studies, multicenter, RCTs, and double-blinded registered trials increased in 2011―2022. The proportion of positive outcomes in pediatric clinical trials sponsored by industries was higher than those sponsored by non-industry. ConclusionThe majority of completed pediatric clinical trials sponsored by industries are for vaccines, in line with the promotion of pediatric policies. The quality of trial registration has improved, but not significantly, and some characteristics of trial design have changed. The proportion of positive outcomes in pediatric clinical trials sponsored by industries is higher. And further promotion of pediatric clinical trials is needed.
ObjectiveTo analyze the characteristics and reporting quality of the registered health Qigong-related clinical trials, and to analyze the progress and shortcomings of health Qigong-related clinical trials.MethodsChinese Clinical Trial Registry (ChiCTR) and ClinicalTrials.gov were electronically searched to collect the health Qigong-related clinical trials from inception to October 15st, 2020. Characteristics of trials were analyzed in the aspects of basic information, funding source, study content and more. The quality of registration was evaluated by WHO Trial Registration Data Set (TRDS).ResultsA total of 121 registered clinical trials were included. The annual registration quantity has been increasing with a peak (33.06%) reached in 2020. Among the registered trials, Baduanjin exercise- related studies accounted for the highest proportion (65.29%). The quantity of studies registered in Shanghai accounted for the most (29.75%). The largest contribution of registered trials was from Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine (5.79%). 50.83% funds in trials were originated from universities and hospitals. Type 2 diabetes, and chronic obstructive pulmonary disease were the most studied diseases in the registered trials. 90.08% trials were designed as randomised parallel control studies, and the sample sizes of trials were concentrated between 30 and 100 (71.07%), and the age of the subjects was distributed over 40 years old (46.15%). The average quality of registration completion of the two registries was 87.44%.ConclusionsAt present, the general trend of health Qigong clinical research is positive. However, these trials contain unbalanced attributes such as the research type of health Qigong, distribution of registration area and organization, allocation of funds, and age composition of subjects. The design of clinical trials and registration details are needed to be improved.
Objective
To explore the certification management of specialty nurses in China based on the existent problems to provide evidence for practice and decision making for management of the specialty nurses.
Methods
The modified Delphi technique was applied in this study from July to December 2017. A structured consultation questionnaire based on expert interview and literature review was designed, and modified after preliminary experiment. Then the questionnaires were delivered to 32 nurse experts to complete 3 rounds of Delphi process, which reached consensus gradually.
Results
The response rates of three round consultations were 96.9% (31/32), 100.0% (31/31), and 96.8% (30/31), respectively. The suggestion rates were 25.8% (8/31), 16.1% (5/31), 0% (0/31), respectively. The familiar coefficient, adjustment coefficient and authority coefficient was 0.82, 0.87 and 0.85, respectively. The experts had the agreement finally for all of the 16 items in the consultation questionnaire, and they formed an expert opinion draft on specialty nurse certification and registration.
Conclusion
It’s crucial and essential to establish a certification and registration system in China and renew the credentials regularly to promote the management and construction of specialty nurse team.
Coronary angiography (CAG) as a typical imaging modality for the diagnosis of coronary diseases hasbeen widely employed in clinical practices. For CAG-based computer-aided diagnosis systems, accurate vessel segmentation plays a fundamental role. However, patients with bradycardia usually have a pacemaker which frequently interferes the vessel segmentation. In this case, the segmentation of vessels will be hard. To mitigate interferences of pacemakers and then extract main vessels more effectively in CAG images, we propose an approach. At first, a pseudo CAG (pCAG) image is generated through a part of a CAG sequence, in which the pacemaker exists. Then, a local feature descriptor is employed to register the relative location of pacemaker between the pCAG image and the target CAG image. Finally, combining the registration result and segmentation results of main vessels and pacemaker, interferences of pacemaker are removed and the segmentation of main vessels is improved. The proposed method is evaluated based on 11 CAG images with pacemakers acquired in clinical practices. An optimization ratio of the Dice coefficient is 12.04%, which demonstrates that our method can remove overlapping pacemakers and achieve the improvement of main vessel segmentation in CAG images.Our method can further become a helpful component in a CAG-based computer-aided diagnosis system, improving its diagnosis accuracy and efficiency.
ObjectiveTo review the registration and technical data for breast implants. MethodsRecent literature concerning registration for breast implants was reviewed and analyzed. ResultsThe aspects on registration for breast implants are complicated. The major aspects include providing technical data, establishing develop standard, progress type test, and developing the registration specification. ConclusionThe manufacturers need to be well aware of the risk of this kind of product and have the full ability to conduct the researching and developing. Only the strict risk controlling can ensure the safety and effectiveness of the product.
Clinical trial, an important research method, plays a crucial role in the development of medicine. It provides important decision support for medical workers. Medical research proposal should be posted at clinical trial registries. Researchers should update original data and research results, which contributes to data sharing. Clinical trial registration can avoid repetitive research and make clinical trials more transparent and standardized. This paper briefly introduces the clinical trial registration, including the definition, the significance, the history, the scope of registration, the organization of registration, and some common problems in the process of registration. Taking the application of clinical trial registration in the field of neurological research as an example, the article describes the current application status of clinical trial registration and explores it’s value and deficiency in specific clinical research, to provoke the awareness on trial registration, which can help to improve the quality of clinical trials.
ObjectiveTo review the registration and technical data for sodium hyaluronate facial derma fillers. MethodsRecent literature concerning registration for sodium hyaluronate facial derma fillers was reviewed and analyzed. ResultsThe aspects on registration for sodium hyaluronate facial derma fillers include nominating the product, dividing registration unit, filling in a registration application form, preparing the technical data, developing the standard, and developing a registration specification. ConclusionThe main difficulty in registration is how to prepare the research data of that product, so the manufacturers need to enhance their basic research ability and work out a scientific technique routing which could ensure the safety and effectiveness of the product, also help to set up the supportive documents to medical device registration.
Objective To evaluate the quality of the registration information for trials sponsored by China registered in the WHO International Clinical Trial Registration Platform (ICTRP) primary registries or other registries that meet the requirements of the International Committee Medical Journal Editor (ICMJE). Methods We assessed the registration information for trials registered in the 9 WHO primary registries and one other registry that met the requirements of ICJME as of 15 October 2008. We analyzed the trial registration data set in each registry and assessed the registration quality against the WHO Trial Registration Data Set (TRDS). We also evaluated the quality of the information in the Source(s) of Monetary or Material Support section, using a specially prepared scale. Results The entries in four registries met the 20 items of the WHO TRDS. These were the Chinese Clinical Trial Registration Center (ChiCR), Australian New Zealand Clinical Trials Registry (NZCTR), Clinical Trials Registry – India (CTRI), and Sri Lanka Clinical Trials Registry (SLCTR). Registration quality varied among the different registries. For example, using the Scale of TRDS, the NZCTR scoreda median of 19 points, ChiCTR (median = 18 points), ISRCTN.org (median = 17 points), and Clinical trials.org (median = 12 points). The data on monetary or material support for ChiCTR and ISRCTN.org were relatively complete and the score on our Scale for the Completeness of Funding Registration Quality ranged from ChiCTR (median = 7 points), ISRCTN.org (median = 6 points), NZCTR (median = 3 points) to clinicaltrials.gov (median = 2 points). Conclusion Further improvements are needed in both the quantity and quality of trial registration. This could be achieved by full completion of the 20 items of the WHO TRDS. Future research should assess ways to ensure the quality and scope of research registration and the role of mandatory registration of funded research.
